Healthy, Type-2 Diabetes
Conditions
Keywords
Diabetes, Hyperglycemia, Healthy, Vildagliptin, Adults
Brief summary
The purpose of this study is to assess the GLP-1 and non-GLP-1 effects of LAF237 on glucagon secretion, using treatment observations of the overall glycemic response.
Interventions
DRUGVildagliptin
DRUGPlacebo
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria - Type-2 Diabetes Patients * Male or female patients aged 30 to 75 years with Type-2 Diabetes Mellitus (T2DM) and who are in otherwise good health * Must have been diagnosed with T2DM at least 6 months prior to screening, and whose diabetes is controlled by diet and exercise alone or by stable dosage ( \> 3 months) of metformin * HbA1c in the range of 6.5% to 9% at screening Inclusion Criteria - Healthy Volunteers * Male or female subjects aged 30 to 75 years, determined to be in good health * Normal oral glucose tolerance test (OGTT) at screening * Age, gender and weight matched to subjects with T2DM
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GLP-1 and non GLP-1 effects of LAF237 on glucagon secretion in patients with Type-2 diabetes and matching healthy subjects | from baseline to Day 10 |
Secondary
| Measure | Time frame |
|---|---|
| Effects of LAF237 on prandial glucose profiles, prandial insulin, and gastric-emptying in patients with Type-2 diabetes and in matching healthy subjects. | 10 day treatment periods |
Countries
Germany
Outcome results
None listed